Land: Armenien
Sprog: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
hexetidine
Bosnalijek d.d.
A01AB12
hexetidine
1mg/ml
solution for topical use
200ml glass vial
OTC
Registered
2018-11-07
1. NAME OF PROPRIETARY MEDICINAL PRODUCT STOMATIDIN ® 0.1% oromucosal solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of oromucosal solution contains: Hexetidine 1.00 mg See point 6.1. for excipients. 3. PHARMACEUTICAL FORM Oromucosal solution. Clear, red solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS STOMATIDIN is indicated for use in minor mouth infections including thrush, as an aid in the prevention and treatment of gingivitis, and in the management of sore throat and recurrent aphthous ulcers. STOMATIDIN is also of value in the alleviation of halitosis and pre- and post-dental surgery. 4.2. DOSAGE AND METHOD OF ADMINISTRATION Usual dosage in adults and children 6 years and over: Rinse the mouth, or gargle with at least 15 ml of undiluted solution, two or three times a day. Do not swallow the solution but spit out after use. 4.3. CONTRAINDICATIONS Hypersensitivity to hexetidine or to any of the excipients in STOMATIDIN (listed in section 6.1.). Children ages to 6 years. 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTION MEASURES STOMATIDIN is for external use only, the solution must therefore not be swallowed. Not suitable for persistent symptoms. STOMATIDIN contains propilenglicol, which may irritate the skin when used locally. STOMATIDIN contains ethanol 96%. 1 ml oromucosal solution contains 80.9 mg ethanol 96%; 15 ml oromucosal solution (single dose) contains 1213.5 mg ethanol 96%. In case of accidental ingestion, it can be harmful for those suffering from alcoholism. It should also be taken into account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease or epilepsy. STOMATIDIN contains azorubine (E122). It may cause allergic reaction (it is important in case of accidental ingestion). 4.5. DRUG INTERACTION OR OTHER INTERACTION FORMS Interactions with other drugs have not been registered. 4.6. PREGNANCY AND LACTATION _Pregnancy _ No formal studies have been conducted in man. However, on the basis of animal studies and, in theo Læs hele dokumentet